Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan

Phase 1

Withdrawn

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Sitaxsentan alone; Drug: Sitaxsentan; Drug: Rifampin

• Registration Number: NCT01251835
• Lead Sponsor: Pfizer

Brief Summary

This study will assess how rifampin will affect the blood levels of sitaxsentan. Safety of sitaxsentan given alone and with rifampin will also be assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-01
• Study First Posted: 2010-12-02
• Status Verified: 2011-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Healthy male subjects and/or women of non-child bearing potential.
• Subjects between the ages of 21 and 55 years, inclusive.
• Signed informed consent.

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
• Has hepatic dysfunction.
• Has history of excessive alcohol and tobacco use.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sitaxsentan	Sitaxsentan alone	-
Sitaxsentan plus Rifampin	Rifampin	-
Sitaxsentan plus Rifampin	Sitaxsentan	-

Primary Outcome Measures

Name	Time	Method
Comparison of Peak Plasma Concentrations of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.	24 hours
Comparison of Area Under the Curve of sitaxsentan co-administered with rifampin versus sitaxsentan administered alone.	24 hours